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Sponsors and Collaborators: |
Amgen National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000626 |
Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease.
Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen.
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Condition | Intervention | Phase |
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HIV Infections Hodgkin's Disease |
Drug: Vinblastine sulfate Drug: Dacarbazine Drug: Filgrastim Drug: Bleomycin sulfate Drug: Doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Official Title: | Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease |
Estimated Enrollment: | 27 |
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Recommended:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Illinois Masonic Med Ctr | |
Chicago, Illinois, United States, 606575147 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Massachusetts | |
Boston Med Ctr | |
Boston, Massachusetts, United States, 02118 | |
United States, Missouri | |
St Louis Regional Hosp / St Louis Regional Med Ctr | |
St. Louis, Missouri, United States, 63112 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10025 | |
United States, Ohio | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
Columbus Children's Hosp | |
Columbus, Ohio, United States, 432052696 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Levine A |
Study ID Numbers: | ACTG 149 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000626 |
Health Authority: | Unspecified |
Granulocyte Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Antineoplastic Agents, Combined |
AIDS-Related Complex Hodgkin Disease ABVD protocol |
Sexually Transmitted Diseases, Viral Dacarbazine Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult Acquired Immunodeficiency Syndrome Vinblastine AIDS-Related Complex Bleomycin Doxorubicin |
Immunologic Deficiency Syndromes Virus Diseases Lymphatic Diseases HIV Infections Sexually Transmitted Diseases Lymphoproliferative Disorders Hodgkin Disease Retroviridae Infections Lymphoma |
RNA Virus Infections Slow Virus Diseases Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Mitosis Modulators Antimitotic Agents Infection |
Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Lentivirus Infections Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents |